Contract development

We are delighted to provide services relating to the development of finished pharmaceutical products, including CTD compilation.

FINISHED DOSAGE FORM DEVELOPMENT

  • Formulation and full laboratory-scale development, including lyophilization cycle development and sterilizing filter validation studies
  • Photostability and in-use studies
  • Production technology development, up-scale and validation of sterile dosage forms – liquid preparations and lyophilized powder preparations in vials
  • Production technology transfer to and from third party
  • Development, validation and transfer of analytical and microbiological methods according to ICH, Ph. Eur. and Russian Pharmacopoeia requirements
  • Development of Finished Dosage Form Registration documentation for EU countries (CTD format)

STABILITY STUDIES FOR FINISHED DOSAGE FORM

  • Transfer of analytical and microbiological methods according to ICH, Ph. Eur. and Russian Pharmacopoeia requirements
  • Long term, accelerated and intermediate stability studies according to ICH guidelines

INVESTIGATION MEDICINAL PRODUCTS (IMP) DEVELOPMENT  

  • IMP formulation improvement for phase I – III studies
  • IMP production technology development in laboratory conditions and up-scale
  • IMP Dossier (CTD) writing for investigational medicinal product